Shilpa Pharma Lifesciences is a trusted end-to-end CDMO (Contract Development and Manufacturing Organization) based in India, delivering API, drug substance, and advanced analytical services to pharmaceutical and biotech partners worldwide. With over three decades of experience, the company supports projects from early development through commercial-scale manufacturing, specializing in small molecules, peptides, HPAPIs, ADC linkers, PEGs, polymers, and specialty chemicals. Shilpa Pharma maintains a strong regulatory track record, including zero-observation USFDA audits, and is recognized by global authorities such as USFDA, EMA, and TGA. The company’s analytical services group offers structure elucidation, impurity evaluation and profiling, standards qualification, method development and validation, polymorph profiling, stability studies, and analytical method transfer, all supported by a dedicated team of PhD scientists and quality experts.
USFDA approved (zero-observation audits), EMA approved, TGA approved, additional global regulatory accreditations and approvals from leading international health authorities. Aligned with sustainability and compliance frameworks including UNGC, SDGs, PSCI, NDC, and SBTi.
Shilpa Pharma’s analytical services follow established global pharmacopeial and ICH-aligned methodologies, including structure elucidation, impurity evaluation and impurity profiling, reference standards qualification, analytical method development and validation, polymorph profiling, photo-stability and forced degradation studies, stability studies, and analytical method transfer protocols โ all conducted under strict quality assurance and data integrity standards.